Single Use Distal Cover Maj-2315

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name: SINGLE USE DISTAL COVER MAJ-2315 FDA UDI
Generic Name: Endoscope patient protection cap, single-use FDA UDI
Model / Reference: MAJ-2315 FDA UDI

Identifiers

Catalog Number: N6192000 FDA UDI
Primary DI / UDI-DI: 04953170441271 FDA UDI
510(k) Number: K220587 FDA UDI
FDA Product Code: FEB FDA UDI
FDT FDA UDI
NWB FDA UDI
GMDN Term: Endoscope patient protection cap, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscope patient protection cap, single-use

Single Use Distal Cover Maj-2315 by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscope patient protection cap, single-use.

PENTAX Medical — HOYA CORPORATION · Class II
DUST CAP, 22F — Intersurgical Incorporated · Class I
SINGLE USE DISTAL COVER — Olympus Medical Systems Corporation · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Olympus Medical Systems Corporation

Sources (1)

FDA UDI 5bdee026-6644-4995-b789-fd9492bfb7f1 34 fields · synced May 30, 2026